Clinical Research Scientist / Senior Clinical Research Scientist

Senior / Clinical Research Scientist  Our client is a pharmaceutical company with a long tradition of designing innovative pharmaceuticals. It is an exciting time within the company as they aggressively expand their portfolio in a new therapeutic direction. They have asked us to assist them in their search for a Senior / Clinical Research Scientist. The Senior/Clinical Research Scientist will complete and manage NDA and ANDA clinical study related activities for drug development projects.  Specific activities will include:  Work with multidisciplinary project teams in preparing and implementing clinical development plans and provide clinical research expertise in support of other departments. Draft, review and issue clinical protocols for phase II-IV clinical studies and bioavailability/bioequivalence studies. Serve as lead sponsor contact with outside organizations such as CRO's, central laboratories, or other clinical research contract organizations. Serve as sponsor contact during CRO selection process. Review, assess and summarize CRO proposals for selection committee. Provide oversight to investigational study centers in the continental United States and Canada in conjunction with Clinical Research Associates. Develop study specific clinical guidelines including CRO oversight procedures, monitoring guidelines and informed consents. Interpret and summarize pharmacokinetic data for NDA and ANDA development candidates. Draft, review and/or finalize reports for both efficacy and pharmacokinetic studies in INDs and NDAs. Draft Clinical Research Standard Operating Procedures and policies for study related activities. Draft medical communications to clinical investigators and Contract Research Organizations from the company. Complete and review clinical literature searches for the new product evaluation process. Prepare draft clinical development plans for new product opportunities. Update and train the Clinical Affairs staff regarding pharmacokinetic issues related to clinical studies.  Serve as a preceptor for pharmacy students and/or clinical research fellows.  We seek candidates with the following qualifications:·  Education: PharmD., PhD or MS degree.  BS is acceptable with extensive knowledge of the drug development process.  ·  Knowledge of pharmacokinetic applications related to drug disposition is desired.·  Experience: 3+ years of drug development experience is desired.  This should include direct industry clinical study participation and/or application of pharmacokinetics in a clinical patient setting (either hospital and/or research setting).  Additional years of experience are required for non-doctoral degree applicants.·  Travel: Up to 30% travel within the continental United States.·  Strong interpersonal, organizational and proofreading skills.·  Ability to perform detail orientated work.·  Understanding of FDA regulations and guidelines. Do you have the skills and experience we seek and want to advance your career with an established yet innovative Mid-West company?  If so, please email your resume as a Word attachment to kim@fcgsearch.com , reference code 2278-M.  No calls or faxes, please.  Include your daytime phone number and we will contact you confidentially or reply to your email.   Fairway Consulting Group is a leading executive search firm dedicated to the pharmaceutical and biotech industries.  www.fcgsearch.com or www.fairwayconsultinggroup.com MRINetwork, one of the world's largest search and recruitment organizations, has over 1,000 offices in more than 35 countries. Each office is a single point of contact that allows candidates to access high-quality positions virtually anywhere in the world. MRINetwork recruiters are industry specialists who typically have real-world experience in the industries they serve. LOCATION: MN JOB CATEGORY: Biotech/R&D/Science TYPE: Full Time, Employee JOB REFCODE: 2278-M COMPANY: Fairway Consulting Group ADDRESS: 300 Merrick Road - Suite 404Lynbrook,NY 11563 PHONE: 516 596-2800 EMAIL: Apply by Email